FDA-Device2014-01-22Class II
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Vital Diagnostics, Inc.
Hazard
High positive calcium bias on plasma sample versus results on serum
Sold states
Nationwide Distribution
Affected count
395 units
Manufactured in
27 Wellington Rd, Lincoln, RI, United States
Products
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0732-2014Don't want to check this manually?
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